If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Weekday Night Shift Supervisor in Boulder, CO, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
~bsp Main Duties and Responsibilities
The Weekday Night Shift Supervisor will start in January 2017 and work Tuesday through Friday nights (10 pm - 8:30 am).
You will be part of our biologics manufacturing team with overall accountability and oversight of the Manufacturing Weekday Night Shift at the Boulder Manufacturing Center. You will have daily supervisory responsibility and perform on-the-floor operations pertaining to the biologics manufacturing in upstream operations in a cGMP environment. You will hire, coach, counsel, train/develop, discipline and recognize direct staff, including annual performance reviews. Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacturing. Execute production and resource schedule against operational plan. You will ensure performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support). You will perform process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements. You'll be responsible for final review of completed manufacturing documentation per compliance standards and established timelines. You will also investigate and resolve problems, identify root cause, and propose process improvements through clear communication to senior management. Interact with outside vendors and senior management. You will participate and/or serve as leadership in multi-functional project teams, as necessary. Help evaluate and establish potential new interdepartmental procedures and practices. Your work will be performed in an environmentally controlled (clean) area. Adherence to all safety rules including the use of Personal Protective Equipment (PPE) is required.
- Five to seven years experience in commercial biologics manufacturing under cGMP with Bachelor's degree; Three to five years experience with a Master's degree; Ten to fifteen year's experience with Associates' Degree; or Fifteen+ years experience with High School education.
- Knowledgeable of the current Code of the Federal Regulations (CFR’s) and Current Good Manufacturing Practices (cGMP’s)
- Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
- Expert knowledge of electronic quality systems
- Possesses strong verbal and written communication skills
- Ability to thoroughly investigate/ perform root cause analysis, identify potential issues and propose solutions through verbal and written communication
- Ability to apply principles of logical or scientific thinking to a wide range of practical problems
- Ability to apply common sense understanding and knowledge of when to stop and seek input and approval from management
- Able to lift up to 30 pounds; able to occasionally sit, stand, bend, squat, kneel and reach above shoulders; will be routinely climbing stairs and or ladders.
- Knowledge and experience in Bioreactor design and SIP/CIP design.
- Strong understanding of aseptic technique and process concepts.
- Monitors daily operations of a unit and actively assists, or provides direction to, subordinates as required
- May perform, especially in staff or professional groups, ongoing operational tasks of organizational unit
- Experience presenting to and interacting with regulatory agencies
- Situational Leadership
- Good organizational skills
- BS/BA degree in biological sciences or biotechnology/life sciences
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law